Body Composition Sub-study of the D2EFT Trial

January 7, 2025 updated by: Kirby Institute
This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. The sub-study will be offered to all D2EFT sites with access to DXA technology for whole-body composition analysis. Sites will offer the sub-study to consecutive clinic patients. Patients must be approached for participation and provide informed written consent prior to randomisation into D2EFT. This study will recruit approximately 300 patients. Allocation to one of three ART treatment regimens will follow the result of D2EFT randomisation. The study will investigate the role of contemporary ART on body composition and metabolic parameters by comparing over 96 weeks the effects of the D2EFT ART regimens. The primary endpoint will be assessed at week 48.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Consenting participants will be randomised within the main D2EFT protocol to receive either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the sub-study is voluntary and not a requirement for enrolment into D2EFT. Parameters relevant to this study including demographics, arm of randomised ART, smoking status, body habitus and fasting lipid parameters and resting blood pressure at required time points will be collected as part of the main D2EFT study. Sub-study specific assessments performed at baseline and at weeks 48 and 96 include clinical and laboratory assessments, sample collection and dual-energy X-ray absorptiometry (DXA)-assessed whole-body composition. Consenting participants will have blood for storage collected at weeks 0, 48 and 96. The specimens will be used for future studies into treatment of HIV infection and immunity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chennai, India, 600113
        • Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Univerity of Malaya Medical Centre
  • South Africa
      • Cape Town, South Africa, 9725
        • Desmond Tutu HIV Foundation
    • Johannesburg
      • Soweto, Johannesburg, South Africa, 2013
        • Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
      • Westdene, Johannesburg, South Africa
        • Clinical HIV Research Unit, Helen Joseph Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre
  • Zimbabwe
      • Harare, Zimbabwe, 263
        • University of Zimbabwe Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Fulfil the criteria for D2EFT randomisation
  • Able to undergo DXA whole-body scanning
  • Provide informed written consent for the D2EFT Body Composition Sub-study

Exclusion Criteria:

  • Unwilling to comply with the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of care
darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd
Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet
800 milligrams (mg) orally once daily for 96 weeks
Other Names:
  • Prezista
Drug: Ritonavir 100 MG Oral Tablet
100 mg orally once daily for 96 weeks
Other Names:
  • Norvir, RTV
Drug: N(t)RTIs
Choice of N(t)RTIs determined by clinician guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection
Other Names:
  • Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]
Experimental: Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)
dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd
Drug: Dolutegravir 50 MG Oral Tablet
50 mg orally once daily for 96 weeks
Other Names:
  • Tivicay, DTG
Drug: TDF 300 MG Oral Tablet
300 mg orally once daily for 96 weeks
Other Names:
  • tenofovir disoproxil fumarate, Viread
Drug: 3TC 300 MG Oral Tablet
300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
Other Names:
  • lamivudine
Drug: FTC 200 MG Oral Cap
200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
Other Names:
  • Emtriva, emtricitabine
Experimental: Dolutegravir + darunavir
dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd
Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet
800 milligrams (mg) orally once daily for 96 weeks
Other Names:
  • Prezista
Drug: Ritonavir 100 MG Oral Tablet
100 mg orally once daily for 96 weeks
Other Names:
  • Norvir, RTV
Drug: Dolutegravir 50 MG Oral Tablet
50 mg orally once daily for 96 weeks
Other Names:
  • Tivicay, DTG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean/median between-group change in waist-to-hip ratio
Time Frame: at 48 weeks
umbilical waist and hip measures
at 48 weeks
Mean/median between-group change in total-to-HDL cholesterol ratio
Time Frame: at 48 weeks
total and HDL cholesterol plasma concentrations
at 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean/median between-group change in total-to-HDL cholesterol ratio
Time Frame: at 96 weeks
total and HDL cholesterol plasma concentrations
at 96 weeks
Mean/median between-group change in waist-to-hip ratio
Time Frame: at 96 weeks
umbilical waist and hip measures
at 96 weeks
Mean/median between-group change in body weight
Time Frame: at week 48 and 96
body weight measurement
at week 48 and 96
Mean/median between-group change in maximum umbilical and hip measures
Time Frame: at week 48 and 96
umbilical waist and hip measures
at week 48 and 96
Mean/median between-group change in fasting lipid parameters
Time Frame: at weeks 48 and 96
total, HDL, and LDL cholesterol and triglyceride plasma concentrations
at weeks 48 and 96
Mean/median between-group change in fasting glycaemic parameters
Time Frame: at weeks 48 and 96
glucose, insulin, HbA1c concentrations
at weeks 48 and 96
Mean/median between-group absolute change in limb fat assessed by DXA
Time Frame: week 48 and 96
absolute change from baseline in limb fat
week 48 and 96
Mean/median between-group percentage change in limb fat assessed by DXA
Time Frame: week 48 and 96
percentage change from baseline in limb fat
week 48 and 96
Mean/median between-group changes in regional body fat assessed by DXA
Time Frame: week 48 and 96
regional = limb fat and truncal fat
week 48 and 96
Mean/median between-group changes in total body fat and lean tissue assessed by DXA
Time Frame: week 48 and 96
total body fat and total lean tissue
week 48 and 96
Mean/median between-group changes in bone mineral content assessed by DXA
Time Frame: week 48 and 96
total bone mineral content
week 48 and 96
Mean/median between-group change in Body Image questionnaire scores
Time Frame: weeks 48 and 96
NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires
weeks 48 and 96
Proportion with Metabolic Syndrome
Time Frame: week 0, and week 48 and 96
baseline prevalence and incidence at weeks 48 and 96
week 0, and week 48 and 96

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean/median between-group change in serum biomarker concentrations
Time Frame: weeks 48 and 96
biomarkers to be determined
weeks 48 and 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirby Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gail Matthews, MBBCh, The Kirby Institute, UNSW Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D2EFT BodyComp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings